ID

28309

Beschrijving

OPTIMOX1 in Chinese mCRC Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01023633

Link

https://clinicaltrials.gov/show/NCT01023633

Trefwoorden

Versies (1)
  1. 03-01-18 03-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

3 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT01023633

Engels

Eligibility Colorectal Cancer NCT01023633

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with histologically confirmed adenocarcinoma of the colon or rectum
Beschrijving

Adenocarcinoma of colon | Adenocarcinoma of rectum

Datatype

boolean

Alias
UMLS CUI [1]
C0338106
UMLS CUI [2]
C0149978
unresectable metastases
Beschrijving

Neoplasm Metastasis unresectable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1519810
at least one bidimensionally measurable lesion of ≥ 1 cm
Beschrijving

Measurable lesion 2-Dimensional Size Quantity

Datatype

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C0449453
UMLS CUI [1,4]
C1265611
no previous chemotherapy for metastatic disease; completed at least more than 1 year oxaliplatin therapy for adjuvant treatment
Beschrijving

Absence Prior Chemotherapy Neoplasm Metastasis | Adjuvant therapy Completed | oxaliplatin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514457
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0205197
UMLS CUI [3]
C0069717
18-75 years old
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
ecog 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy greater than 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
hemogram: wbc≥4.0 x109/l, anc ≥2 x109/l, plt ≥100 x109/l, hb ≥90g/l,
Beschrijving

Hemogram | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0200631
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0518015
adequate renal function
Beschrijving

Renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232804
adequate liver function
Beschrijving

Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
signed informed consent before the treatment
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with previous oxaliplatin based adjuvant chemotherapy within 1 year
Beschrijving

Adjuvant Chemotherapy Oxaliplatin Based

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0069717
UMLS CUI [1,3]
C1705938
completely or partially bowel obstruction
Beschrijving

Intestinal Obstruction Complete | Partial bowel obstruction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021843
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C1328480
presence of peripheral neuropathy (ctc＞grade i)
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
severe mental disorder
Beschrijving

Mental Disorders, Severe

Datatype

boolean

Alias
UMLS CUI [1]
C4046029
cns metastasis
Beschrijving

CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
with other severe disease: uncontrolled active infectious disease, uncontrolled hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia, unstable angina
Beschrijving

Disease Severe | Communicable Disease Uncontrolled | Uncontrolled hypertension | Myocardial Infarction | Cardiac Arrhythmia High risk Uncontrolled | Angina, Unstable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C1868885
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C0332167
UMLS CUI [5,3]
C0205318
UMLS CUI [6]
C0002965
with other malignant disease previously or concurrently
Beschrijving

Cancer Other

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
receive other anti-tumor treatment
Beschrijving

Cancer treatment Other

Datatype

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
pregnant or lactating women, or women of child bearing potential without contraceptive method.
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
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Similar models

Eligibility Colorectal Cancer NCT01023633

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of colon | Adenocarcinoma of rectum
Item
patients with histologically confirmed adenocarcinoma of the colon or rectum
boolean
C0338106 (UMLS CUI [1])
C0149978 (UMLS CUI [2])
Neoplasm Metastasis unresectable
Item
unresectable metastases
boolean
C0027627 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
Measurable lesion 2-Dimensional Size Quantity
Item
at least one bidimensionally measurable lesion of ≥ 1 cm
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C0449453 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Absence Prior Chemotherapy Neoplasm Metastasis | Adjuvant therapy Completed | oxaliplatin
Item
no previous chemotherapy for metastatic disease; completed at least more than 1 year oxaliplatin therapy for adjuvant treatment
boolean
C0332197 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0677850 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0069717 (UMLS CUI [3])
Age
Item
18-75 years old
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than 3 months
boolean
C0023671 (UMLS CUI [1])
Hemogram | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
hemogram: wbc≥4.0 x109/l, anc ≥2 x109/l, plt ≥100 x109/l, hb ≥90g/l,
boolean
C0200631 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0518015 (UMLS CUI [5])
Renal function
Item
adequate renal function
boolean
C0232804 (UMLS CUI [1])
Liver function
Item
adequate liver function
boolean
C0232741 (UMLS CUI [1])
Informed Consent
Item
signed informed consent before the treatment
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Adjuvant Chemotherapy Oxaliplatin Based
Item
patients with previous oxaliplatin based adjuvant chemotherapy within 1 year
boolean
C0085533 (UMLS CUI [1,1])
C0069717 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
Intestinal Obstruction Complete | Partial bowel obstruction
Item
completely or partially bowel obstruction
boolean
C0021843 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1328480 (UMLS CUI [2])
Peripheral Neuropathy CTCAE Grades
Item
presence of peripheral neuropathy (ctc＞grade i)
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Mental Disorders, Severe
Item
severe mental disorder
boolean
C4046029 (UMLS CUI [1])
CNS metastases
Item
cns metastasis
boolean
C0686377 (UMLS CUI [1])
Disease Severe | Communicable Disease Uncontrolled | Uncontrolled hypertension | Myocardial Infarction | Cardiac Arrhythmia High risk Uncontrolled | Angina, Unstable
Item
with other severe disease: uncontrolled active infectious disease, uncontrolled hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia, unstable angina
boolean
C0012634 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1868885 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C0332167 (UMLS CUI [5,2])
C0205318 (UMLS CUI [5,3])
C0002965 (UMLS CUI [6])
Cancer Other
Item
with other malignant disease previously or concurrently
boolean
C1707251 (UMLS CUI [1])
Cancer treatment Other
Item
receive other anti-tumor treatment
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
pregnant or lactating women, or women of child bearing potential without contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
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